{"title":"Clinical performance evaluation of HCV and HIV-1 assays on the fully automated molecular system Alinity m","authors":"Tung Phan , Zachary Cravener , Janet Olean , Melissa McCullough , Jamie Gribschaw , Alan Wells","doi":"10.1016/j.jcvp.2023.100169","DOIUrl":null,"url":null,"abstract":"<div><p>The demand for molecular virology testing continues to grow in clinical laboratories worldwide. The Alinity m system is a fully automated, continuous, random-access molecular diagnostic analyzer that was designed to streamline the laboratory workflow. In this study, we assessed the clinical performance characteristics of the Alinity m HCV and HIV-1 assays to detect and quantify these two bloodborne pathogens in 71 serum and plasma specimens. The overall qualitative agreement between the Alinity m and Abbott m2000 was 100 % for HCV and 94.4 % for HIV-1. Our data demonstrated a weak bias across the quantitative range of the Abbott m2000 and Alinity m HCV and HIV-1 assays, indicating a strong correlation on viral loads between them. Taken together, the Alinity m HCV and HIV-1 assays had comparable results to their current predecessors, the Abbott RealTime HCV and HIV-1 assays.</p></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"3 4","pages":"Article 100169"},"PeriodicalIF":1.6000,"publicationDate":"2023-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of clinical virology plus","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2667038023000364","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
引用次数: 0
Abstract
The demand for molecular virology testing continues to grow in clinical laboratories worldwide. The Alinity m system is a fully automated, continuous, random-access molecular diagnostic analyzer that was designed to streamline the laboratory workflow. In this study, we assessed the clinical performance characteristics of the Alinity m HCV and HIV-1 assays to detect and quantify these two bloodborne pathogens in 71 serum and plasma specimens. The overall qualitative agreement between the Alinity m and Abbott m2000 was 100 % for HCV and 94.4 % for HIV-1. Our data demonstrated a weak bias across the quantitative range of the Abbott m2000 and Alinity m HCV and HIV-1 assays, indicating a strong correlation on viral loads between them. Taken together, the Alinity m HCV and HIV-1 assays had comparable results to their current predecessors, the Abbott RealTime HCV and HIV-1 assays.
全球临床实验室对分子病毒学检测的需求持续增长。Alinity m系统是一种全自动、连续、随机访问的分子诊断分析仪，旨在简化实验室工作流程。在本研究中，我们评估了Alinity m HCV和HIV-1检测的临床性能特征，以检测和量化71份血清和血浆标本中的这两种血源性病原体。Alinity m和Abbott m2000之间的总体定性一致性对HCV为100%，对HIV-1为94.4%。我们的数据表明，在Abbott m2000和Alinity m HCV和HIV-1检测的定量范围内存在微弱的偏差，表明它们之间的病毒载量有很强的相关性。总之，Alinity m HCV和HIV-1检测的结果与目前的前辈Abbott RealTime HCV和HIV1检测的结果相当。
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